During oral intubation, an endotracheal tube is inserted into the patient's trachea. Typically the endotracheal tube is secured to the patient's face by using adhesive tape. The use of tape results in a variety of problems. A problem with adhesive tape is that it must be reapplied in a timely manner. The constant removal and reapplying causes the skin on the face to break down creating sores and leaving the patient susceptible to infection. Tape also does not allow the movement of the endotracheal tube from one spot of the mouth to another to prevent pressure sores caused by the endotracheal tube. The tape also obstructs access to the mouth for routine or emergency care. Furthermore, the patient's secretions cause the tape to lose its adhesive properties and this can cause the endotracheal tube to come out of the patient's trachea.
Previous devices have attempted to solve these problems associated with the use of adhesive tape. However, problems continue to exist and new problems are created in connection with these devices. For example, in Phillips U.S. Pat. No. 2,820,457 (Jan. 21, 1958) and Cheng U.S. Pat. No. 2,908,269 (Oct. 13, 1959), these devices cover the mouth making oral care difficult. Furthermore, during an oral intubation, the endotracheal tube first must be threaded through these devices and then through the patient's trachea. This awkward procedure makes it difficult for the practitioner when inserting the endotracheal tube to visualize the patient's trachea, thus making this device potentially dangerous.
McGinnis, U.S. Pat. No. 4,744,358 (May 17, 1988) relates to an endotracheal tube holder including a rigid endotracheal tube platform having a clamp for clamping an endotracheal tube into a tube channel. The tube platform is supported with respect to the patient's head by a rigid face plate frame secured to the face of a patient by a head harness. The rigid frame rides on the patient's chin. Battaglia U.S. Pat. No. 5,345,931 (Sep. 13, 1994), describes a complicated endotracheal tube holder having many parts including a rigid face plate which is also adapted to ride on the patient's chin. Werner, U.S. Pat. No. 5,419,319 (May 30, 1995) discloses a variable position endotracheal tube holder which includes a face piece having a stiff arcuate transverse portion adapted to pass between the nose and upper lip of the patient, and a pair of downwardly extending wings at either end of the transverse portion. The lateral portion of the face piece has upper and lower flanges which define a groove which receives and retains a movable support for holding the endotracheal tube. These rigid or stiff face plates are not conducive to patient comfort. These devices cover the mouth too much and make it difficult to suction or otherwise provide oral access.
Rogers et al, U.S. Pat. No. 5,555,881 (Sep. 17, 1996) relates to an endotracheal tube holder which has a collar formed from two body portions clamped together to form an adjustable clamping orifice designed to accommodate and grip endotracheal tubes of varying diameters. A padded lip bumper is attached to the endotracheal tube holder.
Smith et al, U.S. Pat. No. 4,592,351 (Jun. 3, 1986) discloses a holder for endotracheal or nasotracheal tubes that comprises a plastic face guard, a plastic tube-grasping section, and a flexible connecting section comprising a unitary sheet of plastic which, once formed, is rendered stiff by the channel constituting the connecting section. The face guard can ride above or below the mouth. The device of Smith does not permit any transverse or longitudinal movement of the tracheal tube when in place in the trachea.
Vrona et al, U.S. Pat. No. 5,490,504 (Feb. 13, 1996) describes an endotracheal tube attachment device for securing an endotracheal tube to a patient and allowing lateral positioning and locking of the tube without removing the tube from the patient. The device comprises an elongated strip made from flexible material which is attached to an upper lip of a patient by an adhesive pad. The tube holder is slideably mounted on a T-shaped track or rail forming part of the strip. The T-shape produces rigidity. The tube holder portion does not provide for any longitudinal movement of the tube once it is in place.
Eross U.S. Pat. No. 3,946,742 (Mar. 30, 1976), discloses a device which, while having some superficial resemblance to the present invention, is vastly different. The Eross device is intended to be strapped on the chin, whereas the present invention is intended to be strapped on the upper lip. The face anchor in the Eross device is a thick plastic. In the present invention, the face anchor is a thin plastic intended to conform to the contours of the patient's face. This difference in the face anchor allows the device of the present invention to be more comfortable. The Eross device has a semi-rigid bite block to protect the endotracheal tube. In the present invention, a bite block is not used, resulting in added comfort to the patient. Both the Eross and the present device swivel on a pivot to move the endotracheal tube from side to side in the mouth, but the device of the present invention also allows the endotracheal tube to move up and down. The Eross device has a neck strap to hold his device, whereas the present invention has two straps to hold a conformable face anchor, which provides far more security without sacrificing comfort. In the present invention, the face anchor rides on the front of the patient's face between the bottom of the nose and the upper lip. In Eross, the entire endotracheal tube holder, riding on the chin, is subject to undesirable movement due to the patient's inadvertent raising and lowering of the mandible. The Eross device does not provide an upward pull to keep the device on the lip and, in fact, the Eross device would tend to slip down and off the lip.
In Muto U.S. Pat. No. 4,223,671 (Sep. 23, 1980), Beran U.S. Pat. No. 4,392,857 (Jul. 12, 1983) and Beran U.S. Pat. No. 4,516,293 (May 14, 1985) these devices cover the mouth, preventing oral care. The devices do not allow the endotracheal tube to be moved for side to side and thus tend to produce pressure sores in the mouth. In addition, Beran's device uses adhesive to secure itself to the patient's face which creates a breakdown on the skin and makes itself susceptible to slippage due to secretions from the patient.
Nestor et al, U.S. Pat. No. 4,249,529 (Feb. 10, 1981) discloses an endotracheal tube holder having a body which is secured by a pair of head encircling straps to overlie the patient's mouth and portions of the cheeks. The straps have one-way tightening adjustability by pawl action.
Nieuwstad, U.S. Pat. No. 5,009,227 (Apr. 23, 1991) relates to an endotracheal tube holder that is provided to hold both an endotracheal tube and a feeding tube in a side by side relationship. Two separate passageways are provided to hold each tube. A surrounding collet provides compression force to hold the endotracheal tube in position relative to the holder.